E-OJ-01 (Oxyjun®), a proprietary, standardized aqueous extract of TA, has been proven to improve cardiac output and thereby lead to better oxygenation capacity and exercise endurance. This, in turn, averts fatigue and improves physical functioning. Based on the previous studies of E-OJ-01 and the scientific literature available in support of the antioxidant and anti- inflammatory activity of TA bark, in the present study, it is hypothesized that E-OJ-01 will be able to reduce fatigue and improve the cardiorespiratory fitness of the male participants aged between 30 to 60 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
74
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
D.Y. Patil deemed to be University,
Nerul, Maharashtra, India
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, India
Shree Ashirwad Hospital
Thane, Maharashtra, India
Jaipur National University Institute for Medical Science and Research Centre
Jaipur, Rajasthan, India
Exercise capacity
To determine the effect of 60 days of product on exercise capacity as assessed by change in time-to-exhaustion (TTE) as evaluated by the Borg RPE scale while running on a treadmill using the Modified Bruce treadmill test protocol compared to the placebo. It is a 15-point single-item scale ranging from 6 to 20, with anchors ranging from 6 "No exertion" to 20 "Maximum exertion"The Borg Score of ≥ 19 will indicate the point of volitional exhaustion, and the exercise protocol will be terminated at this point.
Time frame: Day 0 baseline to Day 60
Cardiorepiratory fitness
The most accurate assessment of VO2 max is made by measuring expired air composition and respiratory volume during maximal exertion. VO2 max can be estimated from the peak exercise intensity during a maximal exercise test. The primary criterion for attaining VO2 max is a plateau in VO2. Several secondary criteria exist in the case of a plateau in VO2 not being reached, which include a rise in respiratory exchange ratio above 1.0 depending on the age, blood lactate concentration above 8 mmol/l, and an increase in heart rate to the age-predicted maximum.
Time frame: Day 0 and Day 60
Exercise-induced fatigue and energy levels
The Visual Analog Scale for energy is anchored with the verbal cues "low" and "high", while VAFS is anchored with the verbal cues "no fatigue" and "very severe fatigue". A higher score indicates higher energy and fatigue on the respective scales
Time frame: Day 0 and Day 60
General fatigue
The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score \< 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis.
Time frame: Day 0, Day 15, Day 30 and Day 60
Physical fatigue
The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score \< 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis.
Time frame: Day 0, Day 15, Day 30 and Day 60
Heart rate at maximal fatigue
Higher the percentile superior is the health
Time frame: Day 0 and Day 60
Mitochondrial biogenesis
Energy balance as assessed by serum PGC-1α levels, a marker of mitochondrial biogenesis.
Time frame: Day 0 and Day 60
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